Obstetric Brachial Plexus InjuryNCT07151053
Duruöz Hand Index in Obstetric Brachial Plexus Palsy
An observational study of Obstetric Brachial Plexus Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Obstetric brachial plexus palsy (OBPP) arises from perinatal injury to the brachial plexus, resulting in varying degrees of motor and sensory impairment in the upper extremity. While existing assessment instruments primarily target unilateral limb function, they frequently overlook bimanual capabilities, which are… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Obstetric Brachial Plexus Injury
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2020to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study cohort consisted of patients who were under regular follow-up at our tertiary care hospital and met the inclusion criteria.
Who may be able to join
- Aged 6 to 18 years
- All diagnosed with OBPP who were followed up at the Physical Medicine and Rehabilitation outpatient clinic of a tertiary university hospital in Turkey.
Who cannot join
- A history of trauma or surgery affecting the function of the affected extremity (other than OBPP)
- The presence of systemic diseases that could impair hand function (such as polyneuropathy)
- Cognitive impairments that could affect comprehension.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa
Istanbul, Fatih, 34093
About this study
Official title: Validity and Reliability of the Duruöz Hand Index in Obstetric Brachial Plexus Palsy
Obstetric brachial plexus palsy (OBPP) arises from perinatal injury to the brachial plexus, resulting in varying degrees of motor and sensory impairment in the upper extremity. While existing assessment instruments primarily target unilateral limb function, they frequently overlook bimanual capabilities, which are essential for functional independence. This study aims to investigate the utility of the Duruöz Hand Index (DHI) as a reliable, valid, and practical instrument for evaluating functional limitations in individuals with OBPP. A cohort of 21 pediatric patients (aged 6-18 years) with OBPP was recruited from a tertiary university hospital in Turkey. Functional assessment included grip and pinch strength, range of motion, and upper extremity performance, measured using the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), and DHI
- Conditions
- Obstetric Brachial Plexus Injury
- Keywords
- Brachial plexus, Duruöz Hand Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Grup 1 | The study included twenty-one children aged 6 to 18 years, all diagnosed with OBPP, who were followed up at the Physical Medicine and Rehabilitation outpatient clinic of a tertiary university hospital in Turkey. The exclusion criteria were a history of trauma or surgery affecting the function of the affected extremity (other than OBPP), the presence of systemic diseases that could impair hand function (such as polyneuropathy), and cognitive impairments that could affect comprehension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and reliability
The primary outcome measure was the Duruöz Hand Index (DHI), which was investigated to determine whether it can adequately capture impairments in bimanual function during daily activities and provide a comprehensive assessment of functional disability in patients with OBPP. To evaluate the validity of the DHI, its correlations with established outcome measures-including the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), as well as grip and pinch strength and range of motion-were examined. Reliability was assessed through internal consistency using Cronbach's alpha.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start5 Mar 2020
- Primary completion1 Apr 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstetric Brachial Plexus InjuryStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilal Kulaksiz, Istanbul University - Cerrahpasa
- Investigators
- Tuğçe Özekli Mısırlıoğlu, Prof., PM&R, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151053
- Sponsor's protocol ID
- 83045809-604.01.02-
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) collected during this study will be shared in an anonymized format. All identifying information will be removed to ensure participant confidentiality, and only de-identified datasets underlying the study results will be made available to qualified researchers upon request
Publications
Misirlioglu TO, Unalan H, Karamehmetoglu SS. Validation of Duruoz Hand Index in patients with tetraplegia. J Hand Ther. 2016 Jul-Sep;29(3):269-74. doi: 10.1016/j.jht.2015.10.001. Epub 2015 Oct 22.
PubMed 26541579Duruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72.
PubMed 8823687O'Berry P, Brown M, Phillips L, Evans SH. Obstetrical Brachial Plexus Palsy. Curr Probl Pediatr Adolesc Health Care. 2017 Jul;47(7):151-155. doi: 10.1016/j.cppeds.2017.06.003. Epub 2017 Jul 12.
PubMed 28709767
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the Duruöz Hand Index in Obstetric Brachial Plexus Palsy
- ClinicalTrials.gov ID
- NCT07151053
- Acronym / sponsor ID
- 83045809-604.01.02-
- Conditions
- Obstetric Brachial Plexus Injury
- Keywords
- Brachial plexus, Duruöz Hand Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstetric brachial plexus palsy (OBPP) arises from perinatal injury to the brachial plexus, resulting in varying degrees of motor and sensory impairment in the upper extremity. While existing assessment instruments primarily target unilateral limb function, they frequently overlook bimanual capabilities, which are essential for functional independence. This study aims to investigate the utility of the Duruöz Hand Index (DHI) as a reliable, valid, and practical instrument for evaluating functional limitations in individuals with OBPP. A cohort of 21 pediatric patients (aged 6-18 years) with OBPP was recruited from a tertiary university hospital in Turkey. Functional assessment included grip and pinch strength, range of motion, and upper extremity performance, measured using the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), and DHI
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Grup 1 | – | –The study included twenty-one children aged 6 to 18 years, all diagnosed with OBPP, who were followed up at the Physical Medicine and Rehabilitation outpatient clinic of a tertiary university hospital in Turkey. The exclusion criteria were a history of trauma or surgery affecting the function of the affected extremity (other than OBPP), the presence of systemic diseases that could impair hand function (such as polyneuropathy), and cognitive impairments that could affect comprehension. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study cohort consisted of patients who were under regular follow-up at our tertiary care hospital and met the inclusion criteria.
Key inclusion criteria (2 listed)
- Aged 6 to 18 years
- All diagnosed with OBPP who were followed up at the Physical Medicine and Rehabilitation outpatient clinic of a tertiary university hospital in Turkey.
Key exclusion criteria (3 listed)
- A history of trauma or surgery affecting the function of the affected extremity (other than OBPP)
- The presence of systemic diseases that could impair hand function (such as polyneuropathy)
- Cognitive impairments that could affect comprehension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Validity and reliability
Time frame: At baseline
The primary outcome measure was the Duruöz Hand Index (DHI), which was investigated to determine whether it can adequately capture impairments in bimanual function during daily activities and provide a comprehensive assessment of functional disability in patients with OBPP. To evaluate the validity of the DHI, its correlations with established outcome measures-including the Modified Mallet Classification, Brachial Plexus Outcome Measure (BPOM), Pediatric Outcomes Data Collection Instrument (PODCI), as well as grip and pinch strength and range of motion-were examined. Reliability was assessed through internal consistency using Cronbach's alpha.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Background: PubMed 26541579Misirlioglu TO, Unalan H, Karamehmetoglu SS. Validation of Duruoz Hand Index in patients with tetraplegia. J Hand Ther. 2016 Jul-Sep;29(3):269-74. doi: 10.1016/j.jht.2015.10.001. Epub 2015 Oct 22.
- Background: PubMed 8823687Duruoz MT, Poiraudeau S, Fermanian J, Menkes CJ, Amor B, Dougados M, Revel M. Development and validation of a rheumatoid hand functional disability scale that assesses functional handicap. J Rheumatol. 1996 Jul;23(7):1167-72.
- Background: PubMed 28709767O'Berry P, Brown M, Phillips L, Evans SH. Obstetrical Brachial Plexus Palsy. Curr Probl Pediatr Adolesc Health Care. 2017 Jul;47(7):151-155. doi: 10.1016/j.cppeds.2017.06.003. Epub 2017 Jul 12.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) collected during this study will be shared in an anonymized format. All identifying information will be removed to ensure participant confidentiality, and only de-identified datasets underlying the study results will be made available to qualified researchers upon request
Related trials for Obstetric Brachial Plexus Injury
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Obstetric Brachial Plexus Palsy
RecruitingObservational study
Evaluation of Pain, Upper Extremity Function, and Social Appearance Anxiety in Adults With Obstetric Brachial Plexus Palsy Who Underwent Shoulder Tendon Transfer Surgery
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
RecruitingObservational study
Validity and Reliability of the Turkish Version of the Impact of Brachial Plexus Injury Questionnaire (IMBPIQ)
Brachial Plexus Birth Palsy, Brachial Plexus Palsy
Recruiting
Sensory Integration Therapy in Children With Congenital Brachial Plexus Injury: Developmental Outcomes
Obstetric Brachial Plexus Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğçe Özekli Mısırlıoğlu, Prof., PM&R study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstetric Brachial Plexus Injury, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and reliability (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07151053, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.